The following data is part of a premarket notification filed by Us Medical Innovations Llc with the FDA for Canady Plasma Electrosurgical Unit Series With Accessory Probes And Blades.
| Device ID | K100669 |
| 510k Number | K100669 |
| Device Name: | CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | US MEDICAL INNOVATIONS LLC 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Contact | Krista Oakes |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-03-09 |
| Decision Date | 2011-04-06 |
| Summary: | summary |